FDA Approval for Animal Drugs
*Routes of Seeking Approval:
For marketing the said drug, any of the four alternatives mentioned below are to be followed:
- An approved New Animal Drug Application (NADA)
- An approved generic application - Abbreviated New Animal Drug Application (ANADA)
- A conditional approval - This pathway is available only for some drugs for use in a minor species or a major species under special circumstances
- An index listing - This pathway is available only for drugs for certain minor species
New Animal Drug Application (NADA)
*FDA Approval Procedure:
FDA approves animal drugs for major species, major uses, minor species, and minor uses. The agency classifies horses, dogs, cats, cattle, pigs, chickens, and turkeys as the seven major species. All other animals, such as fish, ferrets, and goats, are minor species.
- The drug sponsor collects information about the safety and effectiveness of a new animal drug. The sponsor may need to conduct studies to get this information. For any studies that are performed, the sponsor analyzes the results.
- Based on the collected information, the drug sponsor decides if there is enough proof that the drug meets the requirements for approval. The sponsor must prove that the drug is safe and effective for specific use in a specific animal species. If the drug is for food-producing animals, like cows or chickens, the sponsor must also prove that it is safe for people to eat food from treated animals, such as meat, milk, and eggs.
- If the drug sponsor decides that the drug meets the requirements for approval, the sponsor submits a New Animal Drug Application (NADA) to CVM (Center for Veterinary Medicine). The NADA includes all the information about the drug and the proposed label.
- A team of CVM personnel, including veterinarians, animal scientists, biostatisticians, chemists, microbiologists, pharmacologists, and toxicologists, reviews the NADA. If the Center's team agrees with the sponsor's conclusion for the drug being safe and effective when it is used according to the proposed label, CVM approves the NADA, and the drug sponsor can legally sell the drug.
*Requirements of the NADA Form:
(The form may be found at- www.reginfo.gov › public › Download Document)
- Identification of the drug
- Summary concerning the chemical structure, dosage, clinical purpose, highlights of clinical studies, conclusion
- Labeling as per the understanding of a common man
- Components and compositions
- Manufacturing methods, facilities, and controls
- Analytical methods for residues
- Veterinary feed directive
- Applicant's commitments
- Environmental assessment
*Fee for the NADA Form:
|User Fee Type||FY 2021||FY 2020|
|Application Fees -Full||$574,810||$440,446|
|Application Fees -Supplemental||$287,405||$220,223|
*Mode of Filing:
Generic Animal Drug - Abbreviated New Animal Drug Application (ANADA)
*FDA Approval Procedure:
After an approved brand name animal drug has been on the market for a specific number of years, another drug sponsor can start the approval process for a generic copy. (The approved brand name animal drug is also called the 'reference-listed new animal drug product' or the 'pioneer' animal drug) Rather than the full New Animal Drug Application process that a brand name animal drug goes through, a generic animal drug goes through the Abbreviated New Animal Drug Application (ANADA) process. The process is 'abbreviated' because the drug sponsor doesn't have to conduct new safety and effectiveness studies with the generic animal drug. The Generic Animal Drug and Patent Term Restoration Act (GADPTRA) established the approval process for generic animal drugs in 1988.
For CVM to approve a generic animal drug, the information in the ANADA must show that the generic copy has the same quality, performance, and intended uses as the approved brand name drug. The drug sponsor must prove to CVM that the generic copy is the same as the approved brand name animal drug in:
- Active ingredient;
- Dosage form; and
- Dosage regimen, including the route of administration.
The information in the ANADA must also show that the generic copy is bioequivalent to the approved brand name animal drug. It means that the generic drug is absorbed by and performs the same way in the animal's body as the brand name drug.
CVM requires the generic drug to be manufactured under the same strict manufacturing standards as the brand name drug. The manufacturing processes for the generic copy must consistently produce a product that is the same as the brand name animal drug in identity, strength, purity, and quality.
Additionally, the labeling for the generic copy must match the labeling for the approved brand name animal drug. The labeling may differ only in items that are specific to the generic drug, such as trade name, logo, company name, and address.
In 2008, the Animal Generic Drug User Fee Act (AGDUFA) established a 'user fee' system similar to the system for brand name animal drugs. AGDUFA authorizes CVM to collect fees from drug sponsors to support the Center's review of generic animal drugs.
*Requirements of the ANADA Form:
To gain the approval of a proposed generic new animal drug, the ANADA must include identification of the Reference-listed New Animal Drug Product (RLNAD) and information for satisfying the following technical sections:
Bioequivalence - In August 2017, the FDA officially deployed the eSubmitter Blood Level Bioequivalence Study Protocol QbR Template. This template has been designed to increase the transparency and efficiency of the blood level bioequivalence study protocol review process as part of the generic animal drug approval process. If you have questions regarding the eSubmitter Blood Level Bioequivalence Study Protocol QbR Template or would like to obtain a written copy of the template, you may
- Patent Certification and Marketing Exclusivity
- Chemistry and Manufacturing Controls
- Environmental Impact
- Human Food Safety (only applicable when the drug is intended for use in a food-producing animal)
There are two pathways to submit the technical sections for supporting approval of a generic new animal drug. The ANADA form may be submitted as a complete application and reviewed (See 21 CFR 514.1 for more details). The form must be submitted electronically through the eSubmitter portal.
*Fee for the ANADA Form:
|User Fee Type||FY 2021|
|Application Fees – Original||$513,423|
|Application Fee Described in Section 512(d)(4)||$256,712|
*Mode of Filing:
*Kindly Note - Not all Kinds of Animal Drugs Need Approval
Besides approved animal drugs, there are two other categories of legally marketed animal drugs that can be used in animals, depending on the situation. These two categories are as follows:
- 1. Conditionally Approved Animal Drugs: These are available only for some animal drugs for use in a minor species or a major species under special circumstances.
- 2. Indexed Animal Drugs: These are available only for drugs for certain minor species.